NCT06385197

Improving the Effect of Multiple Sclerosis Drugs by Chronobiology

Improving the Effect of Dimethyl Fumarate and Diroximel Fumarate (DRF) for Patients With Multiple Sclerosis by Chronobiology

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

A trial for evaluating the ability to improve the effect of dimethyl fumarate in patients with Multiple Sclerosis (MS) by chronobiology A controlled-randomization dosing regimen administered to patients with MS and provided by a designated app. The treatment limitations of time interval is pre-defined according to approved therapeutic windows.

Detailed description

Dimethyl fumarate (DMF) is an oral option for patients with relapsing forms of MS. The effectiveness of DMF on the clinical and radiological activity of multiple sclerosis were demonstrated in a real-world setting, both in naive patients and in those switching from other multiple sclerosis therapies. Sustained safety and efficacy of DMF was observed in patients continuing on treatment for up to 11 years, supporting DMF as a long-term treatment option for patients with MS. It continues to be an efficacious treatment for multiple sclerosis with a favorable safety profile demonstrated over 10 years of clinical use Patients who have partial response or non-responders in most cases require different medications associated with a less favorable safety profile. Recently fda approved Diroximel fumarate (DRF) is a noval drug which is bioequivalent to DMF regarding efficacy and safety profiles, differing only by chemical precursor structure which is hypothesized to elicit less irritation in the GI tract than DMF. Both drug active metabolites are similar in bioactivity and efficacy treating MS Many aspects of cellular physiology display circadian (approximately 12-h) rhythms. Dysfunction of the circadian clock molecular circuitry is associated with human health derangements, including neurodegeneration, increased risk of cancer, cardiovascular diseases and the metabolic syndrome. Recent evidences support a link between the circadian clock circuitry and biological cycles in multiple systems. Regular dosing of therapy may lead to compensatory mechanisms and are associated with adaptation of the immune system that may prohibit a maximal clinical effect. This open-label study will test the implementation of controlled randomization of time of administration of Dimethyl fumarate to patients with MS. Random changes in the time of administration and dosages of Dimethyl fumarate within pre-defined approved limits which are within the approved therapeutic window will be provided to patient by a designated cellular application. Patients will be followed for 12 weeks for clinical improvement using the Expanded Disability Status Scale (EDSS) and MRI.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DEVICE	App randomizing dosing regimen	patients will receive their dimethyl fumarate treatment and the dose and time of administration will be determined using a designated app.

Timeline

• Start date: 2022-05-08
• Primary completion: 2023-06-01
• Completion: 2023-06-02
• First posted: 2024-04-25
• Last updated: 2024-05-06

Locations

1 site across 1 country: Israel